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NCT07286175PHASE2Recruiting

A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Eli Lilly and Company

Start Date

11/24/2025

Completion Date

11/1/2027

Summary

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria: * Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II * Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as * self-inject study intervention * store and use the provided blinded study intervention, as directed * maintain electronic and paper study diaries, as applicable, and * complete the required questionnaires * Are on stable standard of care medication for bipolar disorder Exclusion Criteria: * Have a lifetime history or current diagnosis of the following according to DSM-5 criteria: * schizophrenia or other psychotic disorder * borderline personality disorder, or * any eating disorder * Have type 1 diabetes mellitus, or a history of * ketoacidosis, or * hyperosmolar state or coma * Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening * Are actively suicidal and or deemed to be at significant risk for suicide * Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

Interventions

DRUG

Brenipatide

DRUG

Placebo

Interested in This Trial?

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Conditions

Bipolar Disorder

Locations

ATP Clinical Research

Orange, California 92866

United States

Yale University School of Medicine

New Haven, Connecticut 06519

United States

AGA Clinical Trials

Hialeah, Florida 33012

United States

Accel Research Sites - Maitland Clinical Research Unit

Maitland, Florida 32751

United States

K2 Medical Research - Maitland

Maitland, Florida 32751

United States

Floridian Clinical Research, LLC

Miami Lakes, Florida 33016-1518

United States

CLA Research

Naples, Florida 34116

United States

Charter Research - Orlando

Orlando, Florida 32803

United States

Encore Medical Research - Weston

Weston, Florida 33331

United States

Atlanta Center for Medical Research

Atlanta, Georgia 30331

United States

Covenant Medical Center

Waterloo, Iowa 50702

United States

CBH Health

Gaithersburg, Maryland 20877

United States

Elixia MA

Springfield, Massachusetts 01103

United States

Adams Clinical Watertown

Watertown, Massachusetts 02472

United States

Penn Medicine: University of Pennsylvania Health System

Philadelphia, Pennsylvania 19104

United States

Revival Research Institute, LLC

McKinney, Texas 75071

United States

Pillar Clinical Research - Richardson

Richardson, Texas 75080

United States

Alpine Research Organization

Clinton, Utah 84015

United States

Re:Cognition Health

Fairfax, Virginia 22031

United States

Northwest Clinical Research Center

Bellevue, Washington 98007

United States

Hospital Italiano de Buenos Aires

ABB, C1199ABB

Argentina

Centro Neurobiológico y de Estrés Traumático (CENydET)

Buenos Aires, 1058

Argentina

Instituto Nacional de Psicopatología (INAPsi)- FunDaMos

Buenos Aires, 1405

Argentina

Stat Research S.A.

Buenos Aires, C1023AAB

Argentina

Mautalen Salud e Investigación

Buenos Aires, C1128AAF

Argentina

Instituto Médico DAMIC

Córdoba, X5003DCE

Argentina

Instituto Kremer

Córdoba, X5004AOA

Argentina

Centro Médico Luquez

Córdoba, X5006CBI

Argentina

Global Psy Asociación Civil

La Plata, 1904

Argentina

Fundacion Scherbovsky

Mendoza, 5500

Argentina

INECO Neurociencias Oroño

Rosario, 2000

Argentina

Clinica El Jardin

Santiago del Estero, 4200

Argentina

Chronos Pesquisa Clínica

Brasília, 72145-450

Brazil

Instituto de Pesquisa clinica de Campinas

Campinas, 13060-080

Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, 17504-072

Brazil

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, 22270-060

Brazil

Facili Centro Integrado de Psiquiatria

São Bernardo do Campo, 09726-150

Brazil

CPQuali Pesquisa Clínica

São Paulo, 01228-000

Brazil

BR Trials - Ensaios Clinicos e Consultoria

São Paulo, 01236030

Brazil

Clinica Viver - Centro de Desospitalizacao Humana

São Paulo, 04020-060

Brazil

A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos

Valinhos, 13271-130

Brazil

The Second People's Hospital of Hunan Province

Changsha, 410007

China

The Seventh People's Hospital of Hangzhou

Hangzhou, 310000

China

3rd People's Hospital of Huzhou

Huzhou, 313000

China

Shangdong Mental Health Center

Jinan, 250012

China

Shanghai Mental Health Center

Shanghai, 200030

China

Shanghai Tongji Hospital

Shanghai, 200065

China

The First Hospital of Hebei Medical University

Shijiazhuang, 050031

China

Tianjin Anding Hospital

Tianjin, 300022

China

Xiamen Xianyue Hospital

Xiamen, 361012

China

Zhumadian Psychiatric Hospital

Zhumadian, 463000

China

Galaxy Superspeciality Hospital

Aurangabad, 431001

India

Belagavi Institute of Medical Sciences - Belagavi

Belgavi, 590019

India

All India Institute of Medical Sciences (AIIMS) - Bhopal

Bhopal, 462024

India

Society for Psychiatric Update and Research

Chhatrapati Sambhajinagar, 431005

India

Graphic Era Institute of Medical Sciences and Hospital

Dehradun, 248008

India

Dharwad Institute Of Mental Health And Neurosciences

Dharwad, 580008

India

Dr. Ram Manohar Lohia Institute of Medical Sciences

Lucknow, 226010

India

Career Institute of Medical Sciences and Hospital - Lucknow

Lucknow, 226020

India

Mysore Medical College

Mysore, 570001

India

Assured Care Plus Hospital

Nashik, 422101

India

Lifepoint Multispeciality Hospital

Pune, 411057

India

Sowmanasya Hospital and Institute of Psychiatry

Tiruchirappalli, 620002

India

Deva Institute Of Healthcare Research

Varanasi, 221005

India

Uematsu Mental Clinic

Chikugo, 833-0041

Japan

Jimbocho Mental Clinic

Chiyoda City, 101-0051

Japan

Horikoshi Mental Somatic Clinic

Fukushima, 960-8053

Japan

Saitama Medical University Hospital

Iruma, 350-0495

Japan

Rainbow and Sea Hospital

Karatsu, 847-0031

Japan

Monzen-nakacho Mental Clinic

Kōtō City, 135-0047

Japan

Suizenji Life Clinic

Kumamoto, 862-0956

Japan

Kure Medical Center

Kure, 737-0023

Japan

Hirota Clinic

Kurume, 830-0033

Japan

Yutaka Clinic

Sagamihara, 252-0303

Japan

Maynds Tower Mental Clinic

Shibuya-ku, 151-0053

Japan

Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi

Tokyo, 162-0843

Japan

Ikebukuro Olive Mental Clinic

Toshima City, 170-0013

Japan

Yamagata Sakuracho Hospital

Yamagata, 990-0045

Japan

Miki Mental Clinic

Yokohama, 220-0023

Japan

Scientia Investigacion Clinica S.C.

Chihuahua City, 31203

Mexico

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, 44650

Mexico

B&B Investigaciones Medicas S.C.

Mazatlán, 82103

Mexico

Centro de Investigación Clinica Chapultepec

Mexico City, 04100

Mexico

Ketamine Clinic México

Mexico City, 04100

Mexico

Medical Care and Research SA de CV

Mérida, 97070

Mexico

Centro de Investigacion Clinica Chapultepec

Morelia, 58260

Mexico

SCB Research Center

Bayamón, 00961

Puerto Rico